Identity
- Trade Name
- Opatrunek Indywidualny W EUDAMED
- Device Name
- Opatrunek Indywidualny W EUDAMED
- Model / Reference
- OW-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905279268029 EUDAMED
- Basic UDI-DI
- 5905279268_OW-1_RT EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Opatrunek Indywidualny W by PARAMEDYK Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5905279268_OW-1_RT | Class I | Active |
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Manufacturer
- Manufacturer
- PARAMEDYK Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004192
Sources (1)
- EUDAMED 68b7e3bb-39e5-44b9-b322-3a39763078a0 61 fields · synced Jul 15, 2026